5 ms·

Instead of just naming the bad actors, what stops the FDA from taking action against them? If there's no generic available for a pill, pharma companies won't ca

Instead of just naming the bad actors, what stops the FDA from taking action against them? If there's no generic available for a pill, pharma companies won't care about bad PR - people have no choice but to buy their product.

JumpCrisscross 8y ago
> what stops the FDA from taking action against them? What law are they breaking?
- maxander 8y ago
  Doesn’t need to be legal enforcement. The FDA could simply start taking its time when issuing new drug approvals, study registration, etc, for bad actors. A substantial quantity of a pharmacy company’s budget and product development cycle is devoted to dealing with the FDA as it is, making it any worse would be a big deal.
  - refurb 8y ago
    The FDA is judged by certain metrics as to their performance (e.g. review time). They'd be hurting themselves if they slowed down.
  - JumpCrisscross 8y ago
    > Doesn’t need to be legal enforcement. The FDA could simply start taking its time when issuing new drug approvals, study registration, etc, for bad actors. The FDA can't take longer because it doesn't like a petitioner. If that were demonstrated, the petitioner would have a case agains the FDA on their hands. Rule of law, and all.
aaavl2821 8y ago
It isn't clear what FDA could actually do in these cases. The companies are basically choosing how to distribute their product, and some pick distributors that make it hard for researchers to access the product I actually started a company a few years back trying to make a generic version of one of these drugs and we found that there are all kinds of FDA-related issues beyond just access to RLDs -- it is a very murky and complex area of drug dev
- refurb 8y ago
  It isn't clear what FDA could actually do in these cases What most of the companies are doing, at the least the ones with "YES" in the "Does the product have a REMS with ETASU Impacting Distribution?" column is conveniently interpreting the law to block generics. ETASU is "Elements to assure safe use". It's a part of the FDA's REMS (Risk evaluation and mitigation strategy). Certain drug have safety risks where the FDA has asked manufacturers to go above and beyond making it "prescription only". REMS can include additional documentation and certification so that doctors prove they understand the risks. It can also include additional documentation for patients. The most strict REMS forces companies to restrict access by limiting the number of pharmacies who can dispense the product and blocking prescriptions where the terms of the REMs haven't been met. It's that last part where the companies are taking a self-serving view of the law. Normally generic companies can request a sample of a branded product (to develop a generic) and the branded company must provide it. With these drugs, the branded company says "but there is no patient! They haven't filled out the forms! We'll get in trouble with the FDA if we do it!" As a result, the FDA has come out a number of times and said "No, providing a sample to a generic company is not a violation of the REMS regulations." This is an attempt to shame the companies into providing samples. The most direct way to fix this is for Congress to tweak the generic drug laws and make it clear not providing a sample, even for REMS drugs is a violation and they can be penalized.
  - aaavl2821 8y ago
    I agree, in the case where there is a REMS, FDA can't do anything, and in the case where there isn't, FDA can do even less. Agreed that a legislative fix seems reasonable. That would actually be a pretty straightforward way to reduce drug prices at least for a subset of drugs. However as weve seen with recent action / inaction on drug pricing, public and bipartisan support of drug price controls + heavy pharma lobbying = watered down legislation / lots of talk and little action

JumpCrisscross 8y ago

> what stops the FDA from taking action against them? What law are they breaking?

maxander 8y ago
Doesn’t need to be legal enforcement. The FDA could simply start taking its time when issuing new drug approvals, study registration, etc, for bad actors. A substantial quantity of a pharmacy company’s budget and product development cycle is devoted to dealing with the FDA as it is, making it any worse would be a big deal.
- refurb 8y ago
  The FDA is judged by certain metrics as to their performance (e.g. review time). They'd be hurting themselves if they slowed down.
- JumpCrisscross 8y ago
  > Doesn’t need to be legal enforcement. The FDA could simply start taking its time when issuing new drug approvals, study registration, etc, for bad actors. The FDA can't take longer because it doesn't like a petitioner. If that were demonstrated, the petitioner would have a case agains the FDA on their hands. Rule of law, and all.

aaavl2821 8y ago

It isn't clear what FDA could actually do in these cases. The companies are basically choosing how to distribute their product, and some pick distributors that make it hard for researchers to access the product I actually started a company a few years back trying to make a generic version of one of these drugs and we found that there are all kinds of FDA-related issues beyond just access to RLDs -- it is a very murky and complex area of drug dev

refurb 8y ago
It isn't clear what FDA could actually do in these cases What most of the companies are doing, at the least the ones with "YES" in the "Does the product have a REMS with ETASU Impacting Distribution?" column is conveniently interpreting the law to block generics. ETASU is "Elements to assure safe use". It's a part of the FDA's REMS (Risk evaluation and mitigation strategy). Certain drug have safety risks where the FDA has asked manufacturers to go above and beyond making it "prescription only". REMS can include additional documentation and certification so that doctors prove they understand the risks. It can also include additional documentation for patients. The most strict REMS forces companies to restrict access by limiting the number of pharmacies who can dispense the product and blocking prescriptions where the terms of the REMs haven't been met. It's that last part where the companies are taking a self-serving view of the law. Normally generic companies can request a sample of a branded product (to develop a generic) and the branded company must provide it. With these drugs, the branded company says "but there is no patient! They haven't filled out the forms! We'll get in trouble with the FDA if we do it!" As a result, the FDA has come out a number of times and said "No, providing a sample to a generic company is not a violation of the REMS regulations." This is an attempt to shame the companies into providing samples. The most direct way to fix this is for Congress to tweak the generic drug laws and make it clear not providing a sample, even for REMS drugs is a violation and they can be penalized.
- aaavl2821 8y ago
  I agree, in the case where there is a REMS, FDA can't do anything, and in the case where there isn't, FDA can do even less. Agreed that a legislative fix seems reasonable. That would actually be a pretty straightforward way to reduce drug prices at least for a subset of drugs. However as weve seen with recent action / inaction on drug pricing, public and bipartisan support of drug price controls + heavy pharma lobbying = watered down legislation / lots of talk and little action